Imatero Special Precautions



Full Prescribing Info
Special Precautions
Imatinib should be taken with food and a large glass of water to minimize the risk of gastrointestinal disturbances.
When Imatinib is co-administered with other medications, there is a potential for drug interactions.
Hypothyroidism: Cases of hypothyroidism have been reported in thyroidectomy patients undergoing Levothyroxine replacement during treatment with Imatinib. TSH levels should be closely monitored in such patients.
Hepatotoxicity: In patients with hepatic dysfunction (mild, moderate or severe), peripheral blood counts and liver enzymes should be carefully monitored (see DOSAGE & ADMINISTRATION, ADVERSE REACTIONS).
When Imatinib is combined with high dose chemotherapy regimens, transient liver toxicity in the form of transaminase elevation and hyperbilirubinemia has been observed. Additionally, there have been reports of acute liver failure. Monitoring of hepatic function is recommended in circumstances where Imatinib is combined with chemotherapy regimens also known to be associated with hepatic dysfunction (see DOSAGE & ADMINISTRATION, ADVERSE REACTIONS).
Fluid retention: Occurrences of severe fluid retention (pleural effusion, oedema, pulmonary oedema, ascites, superficial oedema) can occur in newly diagnosed CML patients taking Imatinib. An unexpected rapid weight gain should be carefully investigated and if necessary, appropriate supportive care and therapeutic measures should be undertaken. Increased incidence of these events in elderly patients and those with a prior history of cardiac disease can occur.
Patients with cardiac disease or renal failure: Patients with cardiac disease or risk factors for cardiac failure should be monitored carefully and any patient with signs or symptoms consistent with cardiac failure should be evaluated and treated.
In patients with hypereosinophilic syndrome (HES) with occult infiltration of HES cells within the myocardium, isolated cases of cardiogenic shock/left ventricular dysfunction have been associated with HES cell degranulation upon the initiation of Imatinib therapy. The condition was reported to be reversible with the administration of systemic steroids, circulatory support measures and temporarily withholding Imatinib.
Myelodysplastic (MDS)/myeloproliferative (MPD) diseases and systemic mastocytosis might be associated with high eosinophil levels. Performance of an echocardiogram and determination of serum troponin should therefore be considered in patients with HES/CEL, and in patients with MDS/MPD or SM associated with high eosinophil levels. If either is abnormal, the prophylactic use of systemic steroids (1 - 2 mg/kg) for one to two weeks concomitantly with Imatinib should be considered at the initiation of therapy.
Tumour lysis syndrome: Cases of tumour lysis syndrome (TLS) have been reported in patients treated with Imatinib. Due to possible occurrence of TLS, correction of significant dehydration and treatment of high uric acid levels are recommended prior to initiation of Imatinib (see ADVERSE REACTIONS).
Laboratory tests: Complete blood counts must be performed regularly during therapy with Imatinib. Treatment of CML patients with Imatinib has been associated with neutropenia or thrombocytopenia. However, the occurrence of these cytopenias is dependent on the stage of the disease being treated and they were more frequent in patients with accelerated phase CML or blast crisis as compared to patients with chronic phase CML. Treatment with Imatinib may be interrupted or the dose may be reduced, as recommended in DOSAGE & ADMINISTRATION.
Liver function (transaminases, bilirubin, alkaline phosphatase) should be monitored regularly in patients receiving Imatinib. As recommended dose in DOSAGE & ADMINISTRATION, non-haematological adverse drug reactions, these laboratory abnormalities should be managed with interruption and/or reduction of the treatment with Imatinib.
Imatinib and its metabolites are not excreted via the kidney to a significant extent. Creatinine clearance (CrCL) is known to decrease with age, and age did not significantly affect Imatinib kinetics. In patients with impaired renal function, Imatinib plasma exposure seems to be higher than that in patients with normal renal function, probably due to an elevated plasma level of alpha-acid glycoprotein (AGP), an Imatinib-binding protein, in these patients. There is no correlation between Imatinib exposure and the degree of renal impairment, as classified by the measurement of creatinine clearance (CrCL), between patients with mild (CrCL: 40 - 59 mL/minute) and severe (CrCL: < 20 mL/minute) renal impairment. However, as recommended in DOSAGE & ADMINISTRATION, the starting dose of Imatinib can be reduced if not tolerated.
Effects on ability to drive and use machines: Reports of motor vehicle accidents have been received in patients receiving Imatinib. Patients should be advised that they may experience undesirable effects such as dizziness, blurred vision or somnolence during treatment with Imatinib. Therefore, caution should be recommended when driving a car or operating machinery.
Use in Children & Adolescents: There can be occur of growth retardation occurring in children and pre-adolescents receiving Imatinib. The long-term effects of prolonged treatment with Imatinib on growth in children are unknown. Therefore, close monitoring of growth in children under Imatinib treatment is recommended (see ADVERSE REACTIONS).
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